Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396162
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2006-11-02
Brief Title:
Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic sinusitis is reported to be one of the most widespread disorders in the United States It can be caused by a variety of reasons such as allergy infection andor defects in T-cells which help regulate immune function Medication and other costs related to treatment of nasal and sinus infections are estimated to be more than 60 million annually putting a considerable strain on the economy of health care
Probiotics are live microorganisms that are normally present in the gut of a healthy individual They are also known as friendly bacteria and have been used to help maintain the normal functioning of the immune system They are safe and are commercially available in the form of yoghurt sachets chewable tablets or flavored capsules Since a number of nasal and sinus disorders are related to allergy and improper functioning of the immune system we hypothesize that regular use of probiotics may help improve chronic nasal and sinus symptoms by boosting immune responses
The project we propose is novel because it would be the first study evaluating the usefulness of probiotics for the larger population having chronic sinusitis rather than those having only allergic symptoms We aim to assess whether regular use of probiotics will help improve symptoms of chronic sinusitis and will have a greater effect than placebo in this regard
Probiotics are live microorganisms that are normally present in the gut of a healthy individual They are also known as friendly bacteria and have been used to help maintain the normal functioning of the immune system They are safe and are commercially available in the form of yoghurt sachets chewable tablets or flavored capsules Since a number of nasal and sinus disorders are related to allergy and improper functioning of the immune system we hypothesize that regular use of probiotics may help improve chronic nasal and sinus symptoms by boosting immune responses
The project we propose is novel because it would be the first study evaluating the usefulness of probiotics for the larger population having chronic sinusitis rather than those having only allergic symptoms We aim to assess whether regular use of probiotics will help improve symptoms of chronic sinusitis and will have a greater effect than placebo in this regard
Detailed Description:
Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host They are a part of the normal gastrointestinal flora and have safely been used to boost immune responses in patients with perennial and seasonal allergic rhinitis Their exact mechanism of benefit is unknown but they primarily help to regulate T-cell function which is important in maintaining immune tolerance
Chronic rhinosinusitis is widely prevalent and affects nearly 16 million people in the US alone each year It puts a strain on the health resources of the nation in terms of costs related to medications and surgery Chronic rhinosinusitis can be caused by a variety of reasons including allergyhypersensitivity infection nasal anatomical variations and T-cell regulatory dysfunction We hypothesize that regular use of probiotics in patients with chronic rhinosinusitis will result in substantial improvement in their symptoms by boosting their immunity and may also help decrease their medication usage
Our study will be a double-blinded randomized control trial We hope to recruit 100 patients from the University Otolaryngology and Allergy Clinics Fifty patients will be randomized to the treatment active arm and 50 patients to the placebo arm Subjects will be followed for 2 months during their period of participation in the study
The main aim of our study is to determine whether regular use of probiotics in patients with chronic rhinosinusitis helps improve their quality of life Our main outcome of interest is a change in the mean score of the Sino-Nasal Outcome Test SNOT-20 form in the treatment group and a greater change in the mean score of the SNOT-20 in the treatment arm as compared to the placebo arm If probiotics are found to be effective they may be used as a cost-effective adjunctive therapy for patients with chronic rhinosinusitis
Chronic rhinosinusitis is widely prevalent and affects nearly 16 million people in the US alone each year It puts a strain on the health resources of the nation in terms of costs related to medications and surgery Chronic rhinosinusitis can be caused by a variety of reasons including allergyhypersensitivity infection nasal anatomical variations and T-cell regulatory dysfunction We hypothesize that regular use of probiotics in patients with chronic rhinosinusitis will result in substantial improvement in their symptoms by boosting their immunity and may also help decrease their medication usage
Our study will be a double-blinded randomized control trial We hope to recruit 100 patients from the University Otolaryngology and Allergy Clinics Fifty patients will be randomized to the treatment active arm and 50 patients to the placebo arm Subjects will be followed for 2 months during their period of participation in the study
The main aim of our study is to determine whether regular use of probiotics in patients with chronic rhinosinusitis helps improve their quality of life Our main outcome of interest is a change in the mean score of the Sino-Nasal Outcome Test SNOT-20 form in the treatment group and a greater change in the mean score of the SNOT-20 in the treatment arm as compared to the placebo arm If probiotics are found to be effective they may be used as a cost-effective adjunctive therapy for patients with chronic rhinosinusitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None